Phase 2 Head and Neck Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People diagnosed with a specific advanced stage of head and neck squamous cell carcinoma (a type of cancer affecting the throat, voice box, mouth, or related areas), confirmed by laboratory testing of tissue or cell samples.
• People whose cancer has not spread to distant parts of the body (classified as M0 disease).
• People whose doctors believe they are able to safely receive the combination of treatments used in this trial.
• People aged 18 or older.
• People with a general health status rated 0 or 1 on a standard medical scale (meaning they are either fully active or have minor limitations but can carry out light work) — (confirm with trial site).
• People whose cancer has at least one measurable area according to standard medical imaging guidelines.
• People with a life expectancy of at least 3 months.
• People whose bone marrow is producing enough blood cells, meeting specific minimum levels for white blood cells, platelets, and red blood cells, without needing recent blood transfusions or certain blood-boosting medications.
• People whose kidneys are functioning well enough to meet specific blood test thresholds.
• People whose liver is functioning well enough to meet specific blood test thresholds, including those with liver involvement from their cancer.
• People whose blood clotting function meets specific test thresholds, including those on blood-thinning medications whose results fall within an acceptable range.
• Women who agree to use contraception during the trial and for 6 months afterward, test negative for pregnancy within 7 days before starting, and are not breastfeeding.
• Men who agree to use contraception during the trial and for 6 months afterward.

Who may not be able to join:

• People who have previously received immunotherapy, radiation therapy, or treatment with a specific type of targeted therapy called EGFR monoclonal antibodies.
• People who have been diagnosed with another cancer (including cancers of unknown origin) in the past 5 years.
• People who cannot tolerate radiation therapy after surgery.
• People with a known allergy to any of the study medications or their ingredients.
• People with serious unstable health conditions, including uncontrolled infections, uncontrolled diabetes, unstable chest pain, recent stroke or mini-stroke, recent heart attack, heart failure, serious irregular heartbeat, or significant liver, kidney, or metabolic problems.
• People with immune system problems, long-term infections (including HIV, hepatitis, or tuberculosis), or autoimmune diseases.
• People with bleeding disorders, a history of significant gastrointestinal bleeding requiring treatment in the past 6 months, or unstable blood clots in the lungs or legs that are not well managed with blood-thinning medication.
• People with a history of, or current signs of, lung inflammation not caused by infection.
• People with active cancer that has spread to the brain or the membranes surrounding the brain or spinal cord, unless the brain metastases were previously treated, have been stable for at least four weeks, are not causing new neurological symptoms, and the person has not needed steroid medications for at least 7 days — cancer involving the membranes (carcinomatous meningitis) is excluded regardless of stability.
• People who have taken certain medications within 7 days before starting the trial that may affect how the study drugs are processed by the body — (confirm with trial site for specific medications).
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period.
• People with any other uncontrolled ongoing illness, including active infections, heart failure, unstable chest pain, or irregular heartbeat.
• People whose heart's electrical activity shows a specific abnormality (QTc interval greater than 475 ms) on a screening heart tracing test.
• People whose heart pumping function falls below 40% on an ultrasound of the heart at screening.
• People with serious medical or mental health conditions, including substance use disorders, that the treating doctor believes could interfere with taking part in or completing the trial.
• People who have needed medical treatment for an active autoimmune disease in the past 2 years — hormone replacement therapies (such as thyroid hormone or insulin) are not considered in this category.

Important: Always verify eligibility with the trial site directly before applying.